Handle assembly for implant delivery apparatus comprising a force limiter, a displacement limiter and/or a brake frame assembly

ABSTRACT

The present invention relates to a handle assembly ( 100 ) for an implant delivery device for folding or unfolding at least one medical implant by means of at least one tension thread, wherein the handle assembly ( 100 ) comprises a drum ( 14 ) for winding the tension thread thereon by rotating the drum ( 14 ); a knob ( 9 ) to be rotated by a user of the handle assembly ( 100 ) in order to fold or unfold the medical implant, the knob ( 9 ) being interconnected with the drum ( 14 ) such that the drum ( 14 ) is rotated when the knob ( 9 ) is rotated; and a force limiter for limiting the maximum force or tension that may be applied or is applicable to the tension thread ( 11 ) or to the drum ( 14 ) by rotating the knob ( 9 ).

The present invention relates to a handle assembly according to claim 1and to an implant delivery apparatus according to claim 8.

From WO 2009/109348 A1, implants are known that can be folded and/orunfolded by means of one or more threads transferring tension onto theimplant. Furthermore, respective apparatuses for folding and unfoldingare known from above mentioned patent application. Such apparatuses areused for both delivering the implant and folding and unfolding theimplant. Folding and unfolding usually takes place by means of a handleassembly comprising a tensioning device for amending the force withwhich tension threads act on the implant.

One object of the present invention is to propose a further handleassembly for an delivery apparatus used for delivering an implant thatmay be folded or unfolded by means of a tension thread. Furthermore, anappropriate implant delivery apparatus is proposed.

This object may be solved in the most general way by a handle assemblycomprising at least one of a force limiter, a displacement limiter and abrake frame assembly.

Further, this object may be solved by any arbitrary combinations offeatures disclosed below. In particular, this object may be solved bymeans of a handle assembly having the features of claim 1. It also maybe solved by an apparatus having the features of claim 8.

Advantageous embodiments or developments of the apparatus according tothe present invention are each subject matter of the dependent claims.

Embodiments according to the present invention may each comprise one ormore of the features disclosed above and/or in the following in anyarbitrary combination.

Thus, according certain embodiments according to the present invention,a handle assembly for an implant delivery device for folding orunfolding at least one medical implant by means of at least one tensionthread is suggested. The handle assembly comprises a drum for windingthe tension thread thereon by rotating the drum. It further comprises aknob to be rotated—or being arranged to be rotatable relative to anothersection of the handle assembly—by a user of the handle assembly in orderto fold or unfold the medical implant by tightening or winding thetension thread or by releasing or unwinding the tension thread. The knobis arranged with or interconnected with the drum such that the drum isrotated when the knob is rotated.

The handle assembly further comprises a displacement limiter forlimiting the length or displacement by which the tension thread may beat least one of wound onto or unwound from the drum by rotating theknob.

Thus, according to particular embodiments of the present invention, ahandle assembly for an implant delivery device for folding or unfoldingat least one medical implant by means of at least one tension thread isproposed. The handle assembly comprises a drum for winding the tensionthread thereon by rotating the drum. It further comprises a knob to berotated by a user of the handle assembly in order to fold or unfold themedical implant. The knob is directly or indirectly interconnected withthe drum such that the drum is rotated when (and/or because) the knob isrotated.

The handle assembly further comprises a force limiter for limiting themaximum force or tension that may be applied or is applicable to thetension thread or to the drum by rotating the knob.

Thus, according to particular embodiments of the present invention, ahandle assembly for an implant delivery device for folding or unfoldingat least one medical implant by means of at least one tension thread isproposed. The handle assembly comprises a drum for winding the tensionthread thereon by rotating the drum. It further comprises a knob to berotated by a user of the handle assembly in order to fold or unfold themedical implant by tightening or winding the tension thread or byreleasing or unwinding the tension thread, the knob being arranged orinterconnected with the drum such that the drum may be rotated when theknob is rotated. The handle assembly of this embodiment furthercomprises a brake frame assembly comprising at least one brake elementand at least one spring arranged to act on the brake element such thatthe brake elements contact one surface of the rear knob.

The implant delivery apparatus according to the present inventioncomprises at least one handle assembly according to the presentinvention.

Whenever numerical values are mentioned herein such as “one”, “two” andthe like, they have to be understood as values representing the lowerthreshold of numerical ranges. A long as this does not result in acontradiction in the eyes of the skilled one, numerical values, such as“one” shall be understood as comprising also “at least one”. Thisinterpretation or understanding is as well encompassed by the presentinvention as the understanding according to which a numerical value suchas “one” may be understood as “exactly one” whenever this appearstechnically possible to the skilled person. Both understandings arecovered by the present invention. This applies to any numerical valuestated herein.

In the following ‘can/may be’ or ‘can/may have’ and so forth has to beunderstood as ‘preferably is’ or ‘preferably has’ and so forth and is tobe understood as be related to an embodiment according to the presentinvention.

In some embodiments according to the present invention, the handleassembly's knob comprises a gear pattern or teeth, e. g. on an inner rimof the knob. In these embodiments, the force limiter comprises orconsists of a first ring element, e. g. a rush gear, comprising a gearpattern or teeth matching or corresponding to the gear pattern or teethof the knob. Further, the force limiter comprises at least one springelement arranged for pressing the first ring element against the knob ina manner such that when a user rotates the knob, in an assembled stateof the handle assembly the first ring element is also rotated because ofthe interaction between the gear pattern or teeth of the knob on the oneside and the gear pattern or teeth of the first ring element on theother side.

In some embodiments according to the present invention, the handleassembly's first ring element comprises teeth on an inner surfacethereof.

In some embodiments according to the present invention, the forcelimiter further comprises a second ring element, e. g. a clutch stopperor a drive wheel. In these embodiments, the spring element is interposedbetween the first ring element and the second ring element and hascontact to both of them.

In some embodiments according to the present invention, one of the firstand the second ring element comprises protrusions, and the other onecomprises or receptions arranged for receiving the protrusions so as toestablish at least one of a form fit and a force disclosure between thefirst and the second ring elements.

In some embodiments according to the present invention, some or all ofthe receptions and the protrusions, respectively, are each arranged aton lower surface of the first ring element and on the upper surface ofthe second ring element.

In some embodiments according to the present invention, the forcelimiter further comprises an internal retaining ring attached within theinner lumen of the knob.

In some embodiments of the present invention, altering a form or shapeof the implant means reducing or increasing a diameter, in particular anouter diameter, of the implant. Alterations of the diameter may beaccompanied by any kind of alteration of the implant's length or anyother alteration, or may be not.

In some embodiments according to the present invention, the drum and theknob are interconnected by a rush gear. The rush gear is arranged torotated inside—and preferably in engagement with—a gear stopper. Thegear stopper, which is preferably arrange inside the rear knob butpreferably not fixed or interconnected to the rear knob resulting inthat the gear stopper and the rear knob can rotate independently fromeach other, is moved along or by means of a gear pattern or teeth whenbeing rotated. The rush gear is interconnected to the drum or to part ofit such that a rotation of the rush gear results in a rotation of thedrum. The displacement limiter comprises or consists of a ring-shaped ortube-shaped element—e.g. a gear stopper—having an inner surface. Theinner surface comprises at least one of a second section having an innersurface different to the inner surface of the first section or a radialwidth (being the distance between the outer surface of the section andthe inner surface thereof) smaller than that of the first section, and athird section having an inner surface different to the inner surface ofthe first section or a radial width smaller than that of the firstsection.

In some embodiments according to the present invention, at least one ofthe second section and the third section does not comprising teeth or agear pattern.

In some embodiments according to the present invention, at least one ofthe second section and the third section is arranged in contact with thefirst section. Alternatively, at least one of them is arranged adjacentto the first section.

In some embodiments according to the present invention, the ring-shapedor tube-shaped element also comprises at least a fourth section on itsinner surface. Preferably, the fourth section does not comprise teeth.The fourth section preferably does not comprise teeth or a gear pattern.The fourth section is separated or delimited from at least one of thefirst or second section by an inclination, an edge, a stop or aprotrusion configured to prevent the rush gear to be rotated furthertowards to or onto the fourth section.

In some embodiments according to the present invention, the innersurface of at least one of the second section and the third section hasa radial distance to the center of the ring-shaped or tube-shapedelement that is larger than a radial distance between the tips of one,some, or the majority of the teeth and the center of the ring-shapedelement.

In some embodiments according to the present invention, the ring-shapedor tube-shaped element comprises at least a first protrusion arranged tointerfere with a second protrusion of the casing assembly or any otherelement of the handle assembly so as to limit the rotation of the rushgear within the ring-shaped or tube-shaped element.

In some embodiments according to the present invention, the at least onefirst protrusion is arranged so as to protrude into an inner lumen ofthe ring-shaped or tube-shaped element.

In some embodiments according to the present invention, the at least onefirst protrusion is arranged between the second and the third sectionsor at the fourth section or opposite the first section of thering-shaped or tube-shaped element or has its base at one of theaforementioned sites.

In some embodiments according to the present invention, the secondsection has at least one of a length, width (in a radial direction) andinclination such that the rush gear may be positioned inside the secondsection such that at least one tooth of the rush gear is engaged with atleast one tooth of the teeth of the first section while at least onetooth of the rush gear is at the same time in contact with theinclination, the edge, stop or protrusion delimiting the second sectionfrom the fourth section or arranged within the second section.

In some embodiments according to the present invention, the thirdsection has at least one of a length, width (in a radial direction) andinclination such that the rush gear may be positioned inside it suchthat one tooth of the rush gear is only half-engaged with at least onetooth of the teeth of the first section while other teeth of the rushgear are at the same time in contact with the inclination, the edge,stop or protrusion delimiting the third section from the fourth sectionor arranged within the second section. “Half-engaged” within the meaningof the present embodiments may be such that rotating the drum in onedirection may not result into rotating the gear stopper as well, whereasrotating the drum in the opposite direction would necessarily result inan functional engagement of the teeth of the drum with the teeth of thefirst section of the gear stopper again. “Half-engaged” may beunderstood such that one tooth of the drum and the last tooth of thefirst section 1911 contact each other temporarily but slip over eachover if the rush gear 16 is rotated in a first direction whereas therush gear 16 and the gear stopper 19 get into normal teeth engagement ifthe rush gear 16 is rotated in the counter-direction.

In some embodiments according to the present invention, the drum issimultaneously engaged (or at least half-engaged as defined above) bothto the rush gear and the gear stopper, or is in contact with both,preferably always.

In some embodiments according to the present invention, the brake frameassembly (25) is configured and arranged to brake a rotation of the rearknob (9) or to prevent the unintended rotation thereof.

In some embodiments according to the present invention, the at least onebrake element is arranged on a frame of the brake frame assembly suchthat the brake element may pivot with respect to the frame.

In some embodiments according to the present invention, the brake frameassembly is arranged inside the rear knob.

In some embodiments according to the present invention, the brake frameassembly has two brake elements arranged opposite to each other.

In some embodiments according to the present invention, the implantdelivery device is designed or embodied as a catheter, in particular aheart catheter, or comprising such a catheter.

In some embodiments according to the present invention, the implantdelivery device comprises at least one implant connected with tensionthreads for the purpose of folding and/or unfolding or provided orprepared for being connected with tension threads.

In some embodiments according to the present invention, the implant is astent or a heart valve arrangement.

In certain embodiments of the present invention, folding the implantmeans reducing the implant's diameter.

In some embodiments according to the present invention, unfolding is tobe understood as increasing a diameter of the implant or as allowing theimplant to increase in diameter by, for example a shape memorycapability plus a sufficient release of the tension thread that wouldotherwise hinder the implant from returning into its original shape.

To “unfold” may, hence, in some embodiments according to the presentinvention be understood as actively releasing the tension acting ontension threads biasing the implant.

In certain embodiments according to the present invention, the implant'sdiameter is present in a plane perpendicular to a main flow direction ofthe implant, in case the implant is flown through by a fluid after itsimplantation.

In some embodiments of the present invention, the at least one tensionthread is a thread or filament or yarn, respectively. It can be designedor embodied similar to a surgical sutural thread or it can be such asurgical sutural thread. It can be designed or embodied as a rope or acord or twine or string, respectively. It can be designed or embodied asa chain comprising a plurality of chain members engaged with adjacentchain members.

In the following, whenever reference is made to a thread or tensionthread, the terms may include a plurality of threads or tension threadsas well insofar as a person skilled in the art recognizes theexchangeability of the terms.

In certain embodiments, the shaft of the apparatus is in at least onesection thereof embodied rigidly. In some embodiments, the shaft of theapparatus is in at least one section thereof embodied such as to bebendable in one or more directions (i. e. it may be bent in alongitudinal direction or in a direction of the shaft's width, in bothdirections or in any other direction). In some embodiments, the shaft isextendable or stretchable. In other embodiments, the shaft is stiff orinflexible.

In some embodiments of the apparatus according to the present invention,during its implanted implantation state, the implant is able to bepenetrated by fluids or is permeable for fluids, respectively, in itslongitudinal direction. The terms “permeable” or “able to be penetrated”hereby refer to the ability of the implant to be penetrated or flownthrough by fluids.

In some embodiments of the apparatus according to the present invention,in the moment of unfolding or folding, the implant is loosely arrangedor attached to or at or on a receiving area of the apparatus. In someembodiments according to the present invention, the implant is therebyconnected with the receiving area only by means of the tension threads.

In certain embodiments of the apparatus according to the presentinvention, the tension thread comprises or consists of a bundle or aplurality of threads or thread elements.

In some embodiments according to the present invention, a shaft of theapparatus is permeable or patent (like a blood vessel) within itsinterior in at least sections of its longitudinal direction or along itsentire length. In those embodiments, the shaft comprises a wall.

In certain embodiments, at least one of the tension threads (or all ofthem) is partly arranged within an inner space of the shaft and extendsfrom there to an outside of the shaft through the shaft opening.

In some embodiments, at least one of the tension threads (or all ofthem) exits from an inner space of the shaft through one shaft opening.In other embodiments, at least one of the tension threads (or all ofthem) exits from the inner space through two or more shaft openings.

In certain embodiments according to the present invention, the at leastone shaft opening is provided at or on the front surface of the shaft.In other embodiments according to the present invention, it is arrangedat or on a circumferential surface or lateral surface area of the shaft.Preferably, the shaft opening is arranged in or within a tip area of theshaft or in or within a proximal area of the shaft.

In certain embodiments according to the present invention, the shaftcomprises a plurality of shaft openings uniformly or non-uniformlydistributed or arranged along or about a periphery or along or about acircumferential surface or lateral surface area of the shaft.Additionally or alternatively, the shaft openings may be dispersed alongor about a longitudinal direction of the shaft. For example, in someembodiments according to the present invention, the shaft may have twoor more shaft openings which are arranged under different distancesbetween the respective opening and the tip or one end of the shaft.

In certain embodiments according to the present invention, the shaft isarranged such that they does no move relatively to the remainingapparatus according to the present invention in a longitudinal directionof the apparatus upon folding or unfolding the medical implant.

In some embodiments according to the present invention, tension threadsfor folding and/or unfolding the implant enter and/or exit through theshaft opening.

In some embodiments according to the present invention, the shaft maycomprise individual shaft fibers as it is disclosed in WO 2012/084178,the respective disclosure is expressly incorporated herein by referencethereto. In particular embodiments according to the present invention,some or all features mentioned herein with respect to the shaft may alsobe comprised by some or all of the individual shaft fibers.

In some embodiments according to the present invention, neither theshaft nor sections thereof are arranged within the interior or materialof a wall of an envelope, an outer boundary or limitation, or the likeof the apparatus.

In some embodiments according to the present invention of the apparatus,the shaft comprises one or more shaft openings. The one or more tensionthreads can enter into and/or exit from the shaft through the shaftopenings.

In certain embodiments according to the present invention, such shaftopenings are solely provided or used for allowing tension threads toenter in or into and/or leave or exit from the shaft.

In some embodiments according to the present invention, the shaft isdesigned or embodied to comprise one or more through-openings (extendinginto a longitudinal direction of the shaft) or one or more hollowinteriors. These through-openings or hollow interiors may allow guidingone or more tension threads through the shaft, e. g. from the tensioningdevice of the apparatus to a shaft opening or to an exit opening at thetip portion of the shaft.

In some embodiments according to the present invention, the tensionthreads are arranged within an interior of the shaft such that they canbe shifted or moved relative to the shaft.

In some embodiments according to the present invention, the shaft and/orthe tension threads do not comprise any devices for establishing a hookengagement with the implant.

In some embodiments according to the present invention, some or all ofthe tension threads are connected with the implant by solely entanglingor entwining the implant or a part or section or portion thereof.

In some embodiments according to the invention, some or all of thetension threads, i.e. at least one tension thread, do not encompass thewhole circumference of the implant. In certain embodiments according tothe invention, one or more of the tension threads re-enter the lumen ofthe implant through apertures provided within the circumference or rimof the implant that are, for example, adjacent to the aperture throughwhich the respective tension thread has exited from the lumen. In someembodiments according to the invention, some or all of the tensionthreads are provided to re-enter the lumen by an aperture provided inthe rim that is different from the aperture through which the particulartension thread has exited from the lumen to an outside of the implant.In particular, any tension thread may re-enter the lumen by the nextaperture, the next but one, next but two, next plus three, or the like,on the circumference or on the rim.

In some embodiments according to the present invention, the apparatus isdesigned or intended for folding and/or unfolding an implant designed asa stent or a heart valve arrangement.

In some embodiments of the set according to the present invention, theimplant is a stent or a heart valve arrangement.

In certain exemplary embodiments according to the present invention, atleast one of the apparatus and the implant comprises exclusively, i.e.only, (one or more) materials that are MRI (short for: magneticresonance imaging) compatible. In certain exemplary embodimentsaccording to the present invention, at least one of the apparatus andthe implant comprises exclusively (one or more) materials that are notmagnetic, ferromagnetic, or both. In some exemplary embodimentsaccording to the present invention, at least one of the apparatus andthe implant does not comprise metal or any metal alloy.

In some embodiments of the set according to the present invention, theimplant is connected or intended to be interconnected with the apparatusby means of tension threads such that the tension threads may act and/orcontact the medical implant not only at one end of the medical implantbut at least at two or more sections of the medical implant which arelongitudinally offset from each other.

In certain embodiments of the present invention, the force limiter, theknob and/or the first ring element of the force limiter, in particularthe inner rim of the knob, for example the gear pattern or teethmatching or corresponding to the gear pattern or teeth of the first ringelement, do not comprise deformable projections or deformable teeth.

In some embodiments of the present invention, the spring element of theforce limiter comprises at least two or more springs or two or more anyother elastic elements.

In certain embodiments of the present invention, the at least two ormore springs or two or more any other elastic elements are arranged,formed and/or disposed, in particular uniformly distributed, in or ontothe first and/or the second ring element, in particular on aperipherical ring or portion of the first and/or the second ringelement.

In some embodiments of the present invention, the first and/or thesecond ring element is not configured, designed, formed and/or shaped asa plate or disk.

In certain embodiments of the present invention, the ring elements arenot connected and/or intended to be connectable to each other through acentral shaft and/or the spring element is not supported and/or arrangedor disposed around a central shaft connecting the ring elements.

The advantages achievable by means of some or all embodiments of thehandle assembly according to the present invention may also be achievedby means of the apparatus according to the present invention.

Some or all of the following advantages and the advantages mentionedabove can be achieved in some, certain or all embodiments according tothe present invention.

In some embodiments according to the present invention, one achievableadvantage is that the force applied on the tension threads by which theimplant is folded or unfolded may not be exceeded. Hence, the risk of atension thread rupture because of undue operation of the handle assemblyis minimized or even completely avoided because of the force limiter. Infact, the tension the tension threads have to stand upon winding themonto the drum is limited to a pre-set maximum value.

Also, the tension threads will stretch under tension. By using the forcelimiter, one can take up the slack caused by this stretching, therebyensuring complete folding.

Also, in certain embodiments according to the present invention, theforce limiter is design as a component allowing patency because of itsoverall ring or tube shape. Hence, the force limiter can be designed tofit into very little space while allow the room it takes to used forother purposes as well. For example, a guide wire may be advancedthrough the inner lumen established by the elements forming the forcelimiter.

In some embodiments according to the present invention, one achievableadvantage is that the implant must not be overly unfolded. In fact,because of the displacement limiter the tension threads cannot bereleased more than it was pre-set as the length by which the tensionthreads may be unwind is limited to a pre-set value by means of thedisplacement limiter. That way, the tension threads will not beover-released beyond the maximum diameter of the stent. Over-releasingcauses the stent/valve to bounce up and down in the blood flow of thebeating heart making positioning difficult. Over-releasing also poses arisk where the strings may come off the stent/valve. This may beadvantageously avoided by the present invention.

In certain embodiments according to the present invention, oneachievable advantage is that the force applied to the force limiter maybe distributed homogeneously through and/or within the spring element.

In some embodiments according to the present invention, one achievableadvantage is that a tilting movement of the first and/or the secondelement, in particular relating to a longitudinal direction of thehandle assembly and/or to a direction going through the centers of bothring elements, may advantageously be reduced or even avoided.

In particular embodiments a sliding of the first and/or of the secondring element, in particular in a direction perpendicular to thelongitudinal direction of the handle assembly and/or to a directiongoing through the centers of both ring elements, may be advantageouslyprevented or avoided.

In certain embodiments according to the present invention, oneachievable advantage is that the spring constant of the individualsprings or corresponding suitable elastic elements can advantageously bereduced compared to or may be lower than the spring constant of a springelement with a single spring (or corresponding single suitable elasticelement) of similar properties.

In some embodiments according to the present invention, the forcelimiter may be of light-weight type, for example in embodiments withoutcentral shaft joining the ring elements.

In the following, the present invention will be exemplarily describedwith respect to the accompanying drawing. In the drawing, same referencenumerals refer to same or identical elements. In the drawing:

FIG. 1 shows a handle assembly according to the present invention in aside view;

FIG. 2 shows the handle assembly of FIG. 1 in a perspective view;

FIG. 3 shows the handle assembly of FIGS. 1 and 2 in an explosion view;

FIGS. 4a-d show different operating modes of the handle of FIGS. 1 to 3;

FIG. 5 shows a rush gear as part of the force limiter of the handleassembly of FIG. 1;

FIG. 6 shows a clutch stopper as part of the force limiter of the handleassembly of FIG. 1;

FIG. 7 shows the rush gear of FIG. 5 together with the clutch stopper ofFIG. 6;

FIG. 8 shows the rear knob as part of the force limiter of the handleassembly of FIG. 1;

FIG. 9 shows the rear knob and the rush gear of the force limiter of thehandle assembly of FIG. 1 in a first perspective view;

FIG. 10 shows the rear knob and the rush gear of FIG. 9 in a secondperspective view;

FIG. 11 shows the rush gear of the force limiter of the handle assemblyof FIG. 1 in connection with a drum for winding a tension thread in aperspective view;

FIG. 12 shows a stopper wheel or gear stopper as part of thedisplacement limiter of the handle assembly of FIG. 1 in a firstembodiment;

FIG. 13a, b show the stopper wheel of FIG. 12 in engagement with a rushgear demonstrating the function of the stopper wheel;

FIG. 14 shows the stopper wheel or gear stopper of FIG. 1 in a secondembodiment in a first state;

FIG. 15 shows the stopper wheel or gear stopper FIG. 14 in a secondstate;

FIG. 16 shows the stopper wheel of FIGS. 14 and 15 in a first plan view;

FIG. 17 shows the stopper wheel of FIGS. 14, 15 and 16 in a second planview;

FIG. 18 shows parts of a brake frame assembly of the handle assembly ofFIG. 1 in a first state;

FIG. 19 shows the parts of FIG. 18 in a second state;

FIG. 20 shows a cover to the parts of FIG. 18;

FIG. 21 shows the assembled brake frame assembly, however without acover; and

FIG. 22 shows a slightly perspective view of a longitudinal section ofthe rear knob of the handle assembly according to the present invention.

FIG. 1 shows a handle assembly 100 according to the present invention ina side view. In FIG. 1, a nose 7, a front knob assembly 23, a middlecasing assembly 24 having a button 12, a rear knob 9, and a rear casingassembly 22 of the handle assembly 100 can be seen.

FIG. 2 shows the handle assembly 100 of FIG. 1 in a perspective view. Inaddition to what is shown in FIG. 1, in FIG. 2 the handle assembly 100is connected a hub dummy 1, an outer tube 2 and an inner tube 4.

The inner tube 4 is in its front section arranged within the outer tube2. The outer tube 2 may comprise further elements besides the inner tube4 such as tension threads or strings (not shown) for folding andunfolding the implant (also not shown).

In certain embodiments according to the present invention, the outertube 2 comprises a first connection device (not shown in the figures)configured to engage with a second connection device (also not shown inthe figures) forming part of a detachable catheter tip carrying theimplant. The first and the second connection device may be configured asplug-in connectors, as crests or crowns or the like, in all casesconfigured to engage with each other.

It goes without saying that with respect to the present invention, thehandle assembly does not need all elements shown in FIG. 1 or 2. Forexample, the present invention can also be carried out with a handleassembly (not shown) which comprises just the rear knob 9, and a rearcasing assembly 22. All other elements described herein are optional.For that reason, whenever it is referred to the hub called “rear” knob 9herein, it is to be understood that the term “rear” has been added inorder to distinguish the (rear) knob 9 from the (front) knob 23. Hence,the rear knob 9 could also be simply referred to as “knob” (without“rear”). The same applies to the rear casing assembly 22 which could aswell be addressed as “casing assembly 22”.

FIG. 3 shows the handle assembly 100 of FIGS. 1 and 2 in an explosionview. As stated with regard to FIGS. 1 and 2, the handle assembly 100may comprise all or only some of the elements shown in FIG. 3. It mayeven consist of those elements. However, the handle assembly 100 may aswell comprise further elements in addition to the ones disclosed in FIG.3.

Further, according to the embodiment according to the invention shown inFIG. 3, some or all of the elements shown in FIG. 3 may be arranged inthe handle assembly 100 in the order or relation to each other shown inFIG. 3. However, the order may be amended in any arbitrary manner aslong as the function of the handle assembly 100 or certain sectionsthereof is still ensured according to the understanding of the skilledperson.

As can be seen from FIG. 3, the front knob assembly 23, the middlecasing assembly 24, the rear knob 9, and the rear casing assembly 22each are comprised or accompanied by further elements.

In particular, the front knob assembly 23 comprises a front knob 10covering a first rod fitting 5 and a second rod fitting 6, the first onebeing larger than the second one. It comprises another tube 3, a firsto-ring 32 (may be metric), a second o-ring 33 (may be metric), severalpan heads 35, also known as pan-head screws, (may be M2×0.4), and asealing pan head 38 (may be M3×0.5).

The front knob 10 may also cover sections of the middle casing assembly24. The middle casing assembly 24 comprises a middle casing 11, a button12, a torsion spring 30, sealed chamber assembly 26, a hex socket setscrew 37 (may be M3×0.5), a drum 14 for winding thereon the tensionthreads used for folding/unfolding of the implant (not shown), a shaftseal 28, a seal chamber pin 18, an o-ring 34 (may be metric), a sealedchamber cover assembly 27, and a rush gear 16.

Parts of the casing assembly 24 are also covered by the rear knob 9. Therear knob 9 comprises a gear stopper 19, a rush gear 15 as an example ofthe first ring element mentioned above and below, some compressionsprings 29 as one example of a spring element, a clutch stopper 13 (ordrive wheel) as an example of the second ring element mentioned above,and an internal retaining ring 39. It also comprises a groove forreceiving the retaining ring 39 in its inner surface.

The rear casing assembly 22 comprises a rear casing 8 covering an end17, a brake frame assembly 25, a torsion spring 31, two brake pads 20, abrake frame 21, some pan heads 35 (may be M2×0.4), and some pan heads 36(may be M2×0.4).

As is evident to the skilled person, the feature combination describedwith respect to FIG. 3 is not the only possible one. In fact, someelements shown in FIG. 3 may be waived upon manufacturing a handleassembly according to the present invention as long as the invention asdefined in its most general way, see above, or by the appended claims isstill reflected by the so composed handle assembly. For that reason, thenumber of the single elements and their arrangement relative to eachother shown in FIG. 3 is to be understood as just one possibleembodiment according to the present invention. Thus, the handle assemblyaccording to the present invention may comprise any arbitrarycombination of features shown in FIG. 3 or even not shown.

Also, whenever some elements have been attributed to a particularcomponent discussed with reference to FIG. 1 it has to be understoodthat certain elements may as well have been attributed to anothercomponent shown in FIG. 1. Also, some elements certainly may beattributed to at least two adjacent components at the same time as theyextend through at least two neighboring components.

FIGS. 4a-d show different modes for operating of the handle of FIGS. 1to 3 according to certain embodiments of the invention.

FIG. 4a shows how the handle assembly 100 can be held whilesimultaneously rotating the rear knob 9 by the operator's thumb. Thatway, the implant can advantageously be folded or unfolded by using justone hand.

FIG. 4b shows how the handle assembly 100 may be held without effectingthe operation sections thereof. By rotating the rear casing assembly 22about its longitudinal axis as is indicated in FIG. 4b , the implant(not shown but connected to the outer tube 2) is also being rotated.Hence, the implant may be properly arranged at the site of itsimplantation, for example within the heart, by rotating the handleassembly 100.

FIG. 4c shows how the button 12 is being pressed (by the thumb of theright hand). Pressing the button 12 allows the front knob assembly 23 tobe rotated (by, for example, the left hand as shown in FIG. 4c ) aboutits longitudinal axis while the button 12 is being pressed or once thebutton 12 was pressed. As long as the button 12 is not depressed or wasnot pressed, the front knob assembly 23 may not be rotated. The outertube 2 comprising the first connection device is interconnected with thefront knob assembly 23 such that rotating the latter results insimultaneously rotating the outer tube 2 and the first connection deviceas these elements are fixed to each other in a compulsory guiding suchthat one cannot rotate while one of the other elements does not rotate.In particular embodiments, rotating the outer tube 2 results inde-clamping of at least one tension thread (not shown) and in releasingit from the implant and/or from the implant delivery device. Hence, thebutton 12 prevents accidental rotation of the outer tube 2 and, hence,in said particular embodiments, unintended de-clamping of the tensionthread. In other embodiments according to the present invention,rotating the outer tube 2 may have a different effect. For example,rotating may activate a cutter used for cutting the tension thread.

It is obvious to the skilled person that any other activation ordeactivation device that allows or forbids rotation of the front knobassembly may be provided instead of the button 12 which only serves asan example.

FIG. 4d shows an alternative way of holding the handle assembly 100 withtwo hands.

FIG. 5 shows a perspective view onto the lower surface of a rush gear 15forming part of the force limiter of the handle assembly 100 of FIG. 1.The rush gear 15 is a ring-shaped element comprising teeth 1511 arrangedat its inner surface 151.

The lower or bottom surface 153 of the rush gear 15 comprises theopenings of at least two receptions 1531 which extend in a directionperpendicular to the lower surface 153.

FIG. 6 shows a perspective view onto the clutch stopper 13 as part ofthe force limiter of the handle assembly 100 of FIG. 1.

On its upper surface 131 the clutch stopper 13 comprise a number of pins1311 (or extrusions or protrusions) extending (preferablyperpendicularly) from the upper surface 131. The pins 1311 (whose numbermay assume, for example, any value between two and 20, preferably 11 or12) are provided to protrude into the receptions 1531 of the lowersurface 153 of the rush gear 15 shown in FIG. 5.

Compression springs 29 (or any other elastic element or material) areprovided in the upper surface 131 of the clutch stopper 13. Inparticular embodiments according to the present invention, thecompression springs 29 are arranged over all or some of the pins 1311.

The embodiment of FIG. 6 comprises twelve compression springs 29.However, their number may vary according to need.

Internal tests have shown that twelve compression springs 29 like theones shown in FIG. 6 are able to provide an appropriate clutch openingforce of 25 N.

In practice, the number and size of the compression springs 29 willdepend on the surface finish and the clearance between the matchingparts.

FIG. 7 shows the rush gear 15 of FIG. 5 together with the clutch stopper13 of FIG. 6. As can be seen from FIG. 7, the pins 1311 of the clutchstopper 13 fit into the receptions 1531 of the rush gear 15.

As can also be seen from FIG. 7, an upper surface 155 of the rush gear15 comprises teeth 1551 or saw-like or wedge-shaped elements acting asclutch elements.

FIG. 8 shows the rear knob 9 (also referred to as hub) as part of theforce limiter of the handle assembly 100 of FIG. 1, again in aperspective view revealing the inner space or the inside of the rearknob 9.

As can be seen from FIG. 8, the rear knob 9 comprises an inner rim 91protruding into the inner space or the lumen of the patency of the rearknob 9. On its lower surface the inner rim 91 comprises teeth orsaw-like or wedge-shaped elements acting as clutch elements.

In use, i.e., in the assembled stated, the rush gear 15 will be insertedinto the lumen of the rear knob 9 such that the teeth 1551 of the rushgear 15 will contact the teeth 911 (see FIG. 10) of the inner rim 91 ofthe rear knob 9 as is shown in FIGS. 9 and 10. That way, the teeth 911of the rear knob 9 and the teeth 1551 of the rush gear 15 will formtogether a clutch. The force needed to release the teeth 911 of the rearknob 9 from the teeth 1511 of the rush gear 15 or to disengage them fromeach other such that no rotation will be transmitted any more by contactof the teeth of the contacting elements depend on the strength of thecompression springs 29 discussed with respect to FIG. 7. In any case,the teeth concerned are formed such that the clutch opens beyond acertain resistance against rotation.

FIG. 9 shows the rear knob 9 and the rush gear 15 (also referred to as adrive wheel) of the force limiter of the handle assembly of FIG. 1 in afirst perspective view. In the embodiment of FIG. 9, the compressionsprings 29 are attached to the rush gear 15.

FIG. 10 shows the rear knob 9 and the rush gear of FIG. 9 in a secondperspective view. As in FIG. 9, in FIG. 10 the two elements are shown ina sort of an explosion drawing showing how they are to be arranged toeach other upon assembling the handle assembly 100.

The rush gear 15 and the rear knob 9 are linked together with the flatgear pattern or teeth 911 comprised by the inner rim 91 at the lowersurface thereof, and the teeth 1551. In use, the rush gear 15 is pushedagainst the inner rim 91 by the compression springs 29 (or any othertype of springs or elastic element) strong enough to maintain theconnection until a pre-set threshold force is exceeded (for example, 25N or 40 N). Above that, the compression springs 9 are not strong enoughand the rush gear 15 disengages from the inner rim 91 to avoid breakingthe tension thread (or string or cable or wire). This way, the forcelimiter limits the force or tension applied or applicable onto thetension thread(s).

The force limiter may include the internal retaining ring 39 shown in,e. g., FIG. 3 and FIG. 22.

FIG. 11 shows the rush gear 15 in engagement with another rush gear 16(also referred to as a pinion). The pinion comprises teeth on its outersurface which engage with teeth 1511 on the inside surface 151 of therush gear 15 and is rotated when the rush gear 15 rotates. The drum 14is in turn connected to the rush gear 16 such that it is rotated oncethe rush gear 16 rotates.

At least one of the drum 14 and the rush gear 16 are arranged so as torotated within the rear knob 9 or within the gear stopper 19 in anexcentric manner (see also FIGS. 14-17).

The drum 14 is arranged to wind the at least one tension thread (notshown in the figures).

FIG. 12 shows the stopper wheel or gear stopper 19 in a first embodimentthereof as part of the displacement limiter of the handle assembly 100of FIG. 1.

The gear stopper 19 is adapted to fit into the lumen of the hub or rearknob 9. It may be arranged within the rear knob 9 such as to rest on theupper surface of the inner rim 91.

The gear stopper 19 may have a ring or a tube shape enclosing an innerlumen or section by an inner surface 191. The inner surface 191 has atleast two different sections or surface qualities or surface features.In other words, the inner surface 191 is not homogeneous.

The gear stopper 19 comprises a rib extending from its inner surfacetowards the inner lumen or section of the gear stopper 19. However, alsopresent, the rib is not shown in FIG. 12 or 13. It is, however, shown inFIG. 3, and also in FIGS. 14-17.

In the example of FIG. 12, at a first section 1911, the inner surface191 comprises teeth 19111. In a second section 1913, the surface 191comprises no teeth. In the example shown in FIG. 12, the second section1913 merely optionally has a width (extending from the inside surface191 to an outside surface 193 of the gear stopper) that is the same (oralmost the same) as the width of the first section 1911 (measured fromthe outside surface 193 to the bottom or origin of the teeth 19111. Theteeth 19111 correspond to the teeth of the rush gear 16 such that therush gear 16 may be moved along the first section 1911 or rotated by thefirst section 1911. That way, the rush gear 16 also shown in FIG. 12 mayas well be moved over from the first section 1911 where its teeth are incontact with the teeth 19111 to the second section 1913 where only someteeth of the rush gear 16 are in contact with the teeth 19111 of thefirst section 1911, while some teeth of the rush gear 16 are not incontact any more. Since some teeth of the rush gear 16 are still incontact with the teeth 19111 of the gear stopper 19 when the rush gear16 has reached the second section 1913, the rush gears 16 can be broughtback from the second section to the first section by means of thematching teeth by simply changing its rotational direction.

The second section 1913 is adjacent to the first section 1911 orcontacts it (as a neighboring section).

As can be seen from FIG. 12, the second section 1913 is more or less arecess 19133 or inclined surface which is delimited or bordered by thelast tooth of the first section 19111 on one side and by an inclinationor edge 19131 delimiting the opposite side of the recess 19133 definingthe second section 1913.

Instead of the edge 19131 or protrusion or the like, any device might beused for stopping a further movement of the rush gear 16. For example,the second section 1913 might as well (or alternatively) have a stop, aninclination, a broader (in a radial direction) subsection, or the like,as long as the stop, an inclination, a broader (in a radial direction)subsection, or the like engages with the teeth of the rush gear 16 suchthat it prevents further rotation (even without lateral movement) of therush gear 16. That way, the edge, the stop, the inclination, the broader(in a radial direction) subsection, or the like does engage with atleast one of the rush gears' teeth.

The second section 1913 has a length (in a circumferential direction)such that the diameter of the rush gear 16 is large enough to engagewith at least one (preferably more that one) teeth 19111 of the firstsection 1911 and, at the same time, to contact or to reach the edge19133 delimiting the recess 19133. That way, once the rush gear 16 ispositioned within the second section 1913, a further movement of therush gear 16 away from the first section 1911 (i.e., in the clockwisedirection in FIG. 12) is prevented, either by the edge or by theinclination shown in FIG. 12. At the same time, since it is still incontact with at least one tooth of the first section 1911 as explainedabove, it can always be rotated by the teeth 19111.

In the particular and exemplary embodiment of FIG. 12, the inner surface191 additionally comprises a third section 1915 and a fourth section1917.

The third section 1915 may be designed like the second section 1913 inthat it has the same width (or radius) and/or an inclination and/or alsono teeth. However, the second section 1913 and the third section 1915may differ in their length and/or other geometrical features. Also, likethe second section 1913 the third section 1915 may also contact thefirst section 1911, for example as shown in FIG. 12 (the second and thethird sections are arranged at opposite ends of the first section).

The third section 1915 may be longer than the second section 1913.

Also, like the second section 1913, the third section 1915 may have aninclination, edge 19151, protrusion or the like, or any device might beused for stopping a further movement of the rush gear 16. For example,the second section 1915 might as well (or alternatively) have a stop, aninclination, a broader (in a radial direction) subsection, or the like.

Like the second section 1913, the third section 1915 limits the movementof the rush gear 16 by means of an edge or the like contacting the rushgear' teeth. As can be seen in FIG. 12, the further movement (in alateral or circumferential direction along the inner rim of the stoppergear 19) of the rush gear 16 is restricted or stopped by a stop, aninclination, a broader (in a radial direction) subsection, or the like,that does not contact the teeth of the rush gear 16. At the same time,the third section 1915 is not long enough to allow the teeth of the rushgear 16 to become disengage from all teeth 19111 of the first section1911. Rather, the dimensions of the third section 1915 and the rush gear16 are chosen such that at least or only the last tooth of the teeth19111 of the first section 1911 will always remain half-engaged with theteeth of the rush gear 16. That way, the rush gear 16 can always bereturned or moved back towards the first section 1911, again by simplychanging the direction of rotation.

In contrast to the when the rush gear 16 is definitely one of blockedand immobilized in the second section 1913, the rush gear 16, whenpositioned in the third section 1915, may still be rotated. When it isrotated away from the first section 1911, the last tooth will berepeatedly overleaped which results in a funny, machinery noise of teeththat do not properly engage with each other while being moved withrespect to or along each other, also known from improper operation ofcar gear boxes upon changing gears.

The fourth section 1917 is also optional. It may be arranged oppositethe first section 1911. It may or may not contact the first section1911. It may have teeth or no teeth.

FIG. 13a shows the wheel stopper or gear stopper 19 in engagement withthe rush gear or pinion 16. The rush gear 16 is positioned within thethird section 1915, which is toothless. The gear stopper 19 ispositioned within the rear knob or hub 9 without being fixed. Rather,the gear stopper 19 is held within the rear knob 9 acting as a casingfor the gear stopper 19. The gear stopper 19 may, however, rotate withinthe rear knob 9 and relative thereto. Hence, when being further rotatedin the direction indicated by the arrow by operating the rear knob 9,for lack of engaging teeth, the rush gear 16 cannot be rotated anyfurther down. Also, the optionally provided inclination of the thirdsection 1915 hinders the rush gear 16 to move further on along the innersurface of the gear stopper 19. This limits the rotatability of both thegear stopper 19 and the rear knob 9.

FIG. 13a shows how the gear stopper 19 and the rush gear or pinion 16are positioned relative to each other in a state in which the implant ismaximally folded.

In the state shown in FIG. 13a , the rib of the gear stopper 19 (onlyshown in FIGS. 14 and 15) abuts the rib of the rib of the casing, or thegear stopper 19 is stopped by the rib touching some element of thecasing other than the rib, such that the gear stopper 19 can not berotated any further. Hence, the rush gear 16 also can not be rotated anyfurther. Thus, any intention of the user to rotate the knob any furthermust be in vain in that the rush gear 16 and, thus, the drum 14 will notbe rotated any further and the tension thread will not be wound anyfurther. Rather, what happens once the rush gear's rib has come to ahalt is that the force limiter of the handle assembly 100 will come intoplay and the clutch comprised by the rear knob 9 will open against theforce of the springs 29. In consequence, the rear knob 9 might still berotated even if the rush gear 16 has entered the third section 1915.However, its rotation is no longer transmitted onto the drum 14 and thetension thread is no longer wound or further tensioned.

FIG. 13b shows how the gear stopper 19 and the rush gear or pinion 16are positioned relative to each other in a state in which the implant ismaximally unfolded. The rush gear 16 is positioned inside the secondsection 1913, which is toothless. Hence, when being further rotated inthe direction indicated by the arrow by rotating the rear knob 9, forlack of teeth, the rush gear 16 cannot be rotated any further.

In the state shown in FIG. 13b , if the user should intend to furtherrotate the rear knob 9 once the rush gear 16 has entered the secondsection 1913, the rush gear 16 would not get over the inclination oredge 19133. Rather, the inclination or edge 19133 would block anyfurther rotation of the rush gear 16 and the drum 14, wherefore thetension thread can not be released any further. That way, thedisplacement of the tension thread is limited. The rush gear 16 wouldnot slip or turn freely as it does inside the third section 1915 asdescribed supra. The ribs discussed above are not in contact with eachother in this state. Also, the force limiter or its clutch does notopen. No noise of slipping teeth will be heard.

FIG. 14 shows a stopper wheel as part of the displacement limiter of thehandle assembly of FIG. 1 in a second embodiment and in a first state.

In contrast to the FIGS. 12, 13 a and 13 b, the protrusion of the gearstopper 19 which may be a rib, is shown in FIG. 14. It is depicted withreference numeral 195. The rib, also referred to as spring rib,protrudes into the lumen of the gear stopper 19.

As can be seen in FIG. 14, in this embodiment only, the rear part of themiddle casing assembly 24 also comprises a protrusion, e. g. a rib,referred to hereinafter as second rib 241. The second rib 241 isarranged on the casing, and the first rib 195 is arranged on the gearstopper 19 such that the first rib 195 is placed at the left side (orabove the second rib 241) when the gear 19 has reached the third section1915 of the gear stopper 19.

It goes without mentioning that instead of the first and secondprotrusion any other form and shape a stop or a pair of matching stopswill do as well, which is also encompassed by the present invention.

FIG. 14 shows the displacement limiter in a state in which the secondrib 241 hinders the gear stopper 19 from being further rotated in theanticlockwise direction (related to the illustration of FIG. 14) becauseof the contact between the ribs 195 and 241. Hence, the tension threadcannot be wound any further by rotating in the anticlockwise direction.In FIG. 14, the rush gear 16 is positioned in the third section 1915.When positioned in the third section 1915 of this exemplary embodiment,the teeth of the rush gear 16 do not contact an inclination or stop orthe like of the third section 1915. The movement of the gear stopper 19is stopped only by the contacting ribs 195, 241. The rush gear 16 mayrotate freely in one direction, but it cannot create relative movementbetween itself and the gear stopper 19.

FIG. 15 shows the stopper wheel or gear stopper 19 of FIG. 14 in asecond state.

FIG. 15 shows the displacement limiter in a state in which the secondrib 241 does not hinder the gear stopper 19 from being further rotatedin the anticlockwise direction (related to the illustration of FIG. 14).Hence, the tension thread can not be unwound further by rotating in theclockwise direction. However, it cannot be released any more since therush gear 16 is blocked in the second section 1913 as describe above. InFIG. 15, the rush gear 16 is positioned in the second section 1913.

FIG. 16 shows the stopper wheel of FIGS. 14 and 15 in a first plan view.In FIG. 16, the gear stopper 19 takes the position relative to the rushgear 16 it also takes in FIG. 14. As can be seen, the teeth of the rushgear 16 are not in full contact with the last tooth of the first section1911. Rather, the last tooth is half-engaged so that upon rotating therush gear 16 in the clockwise direction, its teeth will automaticallyget engaged again with the first tooth of the first section 1911 firstand, in consequence, with the remaining teeth 19111 of the first section1911 as well.

FIG. 17 shows the stopper wheel of FIGS. 14, 15 and 16 in a second planview. In FIG. 17, the gear stopper 19 takes the position relative to therush gear 16 it also takes in FIG. 15. As can be seen, the teeth of therush gear 16 are still in full contact with not only the last tooth ofthe first section 1911. At the same time, the rush gear 16 contacts theedge 19131 of the second section 1913. Hence, the rush gear 16 thatmoves on a constant radium about a rotation axis extending through thecenter of the gear knob 19 may not be rotated further in the clockwisedirection. It is blocked in the state shown in FIG. 17 regarding anyfurther rotation in the clockwise direction. It may, however, be rotatedin the anticlockwise direction.

FIG. 18 shows parts of a brake frame assembly 25 of the handle assemblyof FIG. 1 in a first state which is a state before the brake frameassembly 25 has been fully assembled.

The parts brake frame assembly 25 which are shown in FIG. 18 are a firstframe 251 and a first half-wheel 253, the latter being an example of abrake element. Other examples of the brake elements also encompassed bythe present invention include a brake pad and a brake shoe.

The first half-wheel 253 is interconnected with the first frame 251 inmanner such that the first half-wheel 253 may pivot relative to thefirst frame 251.

FIG. 18 shows not all parts of the brake frame assembly 25. In theexemplary embodiment shown only in parts in FIG. 18, the complete brakeframe assembly 25 comprises not only the first frame 251 and the firsthalf-wheel 253 but also a second frame (not shown in FIG. 18 but in FIG.21 as second frame 252) and a second half-wheel (also not shown in FIG.18 but in FIG. 21 as second half-wheel 254). Moreover, the assembly 25comprises two springs 256, 257 which are also not shown in FIG. 18 butindicated in FIG. 3 and shown in FIG. 21. Finally, the first frame 251and the second frame 252 are interconnected to each other by screws asshown in FIG. 3 and in FIG. 21.

In the assembled state, the first and second frames 251, 252 serve ascovers that sandwich the two half-wheels 253, 254 and the two springs256, 257 between them.

In the particular embodiment of FIG. 18, the first and second frames251, 252 have a round periphery. Also, the brake frame assembly 25 hasan through-opening in its center, which may be rectangular in shape. Therectangular shape shown in FIG. 18 is configured to correspond to thecross section of the middle casing assembly 24.

As stated above, none of the two springs 256, 257 (or other elasticelements) of the brake frame assembly 25 are shown. In practice, one ofthese springs is attached between the first half-wheel 253 and the firstframe 251 such that the spring keeps the half-wheel 253 in the positionrelative to the first frame 251 as shown in FIG. 18. The other springwill do the same with the second half-wheel (not shown in FIG. 18) inthe lower part of FIG. 18.

In the exemplary embodiment of FIG. 18, the springs are inserted intogrooves seen in FIG. 18. However, any suitable protrusion or the likewill do as well.

In the example of FIG. 18, the springs are selected and arranged so asto stay open as it is shown in FIG. 18 such that it takes effort toclose its spring arms (whereas with other springs it needs effort toopen them). That means it takes effort to bring the first half-wheel 253shown in FIG. 18 into its position shown in FIG. 19. The position of thefirst half-wheel 253 shown in FIG. 18 does not reflect its position in afully assembled state of the brake frame assembly 25.

It goes without explanation that instead of two springs and two brakeelements one of each will also do.

FIG. 19 shows the parts of FIG. 18 in a second state. The second stateshows the position of the half-wheel 253 in a fully assembled state ofthe brake frame assembly 25.

Although no springs are shown in FIG. 19, it can easily be understoodthat the curved surface of the half-wheel 253 may be urged over theouter shape or the circumference of the brake frame assembly 25, hereexemplarily over the outer shape or the circumference of the first frame251, and, in a full assembly state of the handle assembly 100, againstan inner surface of the rear knob 9 inside of which the brake frameassembly 25 is arranged during use. Since the brake assembly 25 isarranged in a rotationally stable manner with respect to the middlecasing assembly 24 such that the brake frame assembly 25 cannot rotatewith respect to the handle assembly 100, whereas the rear knob 9 can,the first (and, if provided, also the second) half-wheel 253 causesfriction and brakes the rotation of the rear knob 9. The degree of thebraking effort certainly depends on the spring force and on thecombination of the materials of the braking partners (i.e. the brakeelement and the inner surface of the rear knob 9). In any case, thebraking efficiency will be chosen to be small enough so that the rearknob 9 still may be rotated by hand, and at the same time strong enoughso that the memory shape effect of the implant or other forces applyingto the implant or the tension thread(s) wound onto the drum 14 may notrotate the rear knob 9 by themselves.

FIG. 20 shows a cover to the parts of FIG. 18. It may be referred to asa second frame 252 in the sense discussed above with respect to theFIGS. 18 and 19.

FIG. 21 shows the almost fully assembled brake frame assembly 25 of thepreceding figures. What is missing is the second frame 252. The assembly25 is arranged within the rear knob 9. The springs 256, 257 press thehalf-wheels 253, 254 against the inner surface of the rear knob 9.

FIG. 22 shows a slightly perspective view of a longitudinal section ofthe rear knob 9 of the handle assembly 100 according to the presentinvention. The front part of the rear knob 9 is in the upper part ofFIG. 22.

As can be seen in FIG. 22, the rush gear 16 is arranged within the rearknob 9 such that it engages with both the gear stopper 19 and the rushgear 15 of the force limiter.

REFERENCE NUMERALS

-   100 handle assembly-   1 hub dummy-   2 outer tube-   3 tube-   4 inner tube-   5 first rod fitting-   6 second rod fitting-   7 nose-   8 rear casing-   9 rear knob-   91 inner rim-   911 gear pattern or teeth of inner rim-   10 front knob-   11 middle casing-   12 button-   13 clutch stopper-   131 upper side-   1311 pin or protrusion-   14 drum-   15 rush gear-   151 inner surface-   1551 teeth-   153 lower surface-   1531 reception-   155 upper surface-   1551 teeth-   16 rush gear-   17 end-   18 seal chamber pin-   19 gear stopper or stopper wheel or ring-shaped element-   191 inner surface-   1911 first section of the inner surface of the gear stopper-   19111 teeth-   1913 second section of the inner surface of the gear stopper-   19131 edge-   19133 recess-   1915 third section of the inner surface of the gear stopper-   19151 edge-   1917 fourth section of the inner surface of the gear stopper-   193 outer surface-   195 first protrusion, e. g. a rib-   20 brake pad-   21 brake frame-   22 rear casing assembly-   23 front know assembly-   24 middle casing assembly-   241 second protrusion, e.g. a rib-   25 brake frame assembly-   251 first frame-   252 second frame-   253 first half-wheel-   254 second half-wheel-   256 first spring-   257 second spring-   26 sealed chamber assembly-   27 sealed chamber cover assembly-   28 shaft seal-   29 compression spring-   30 torsion spring-   31 torsion spring-   32 metric o-ring-   33 metric o-ring-   34 metric o-ring-   35 pan head-   36 pan head-   37 hex socket set screw-   38 sealing pan head-   39 internal retaining ring

1. A handle assembly (100) for an implant delivery device for folding orunfolding at least one medical implant by means of at least one tensionthread, wherein the handle assembly (100) comprises: a drum (14) forwinding the tension thread thereon by rotating the drum (14); a knob (9)to be rotated by a user of the handle assembly (100) in order to fold orunfold the medical implant, the knob (9) being interconnected with thedrum (14) such that the drum (14) is rotated when the knob (9) isrotated; and a force limiter for limiting the maximum force or tensionthat may be applied or is applicable to the tension thread (11) or tothe drum (14) by rotating the knob (9).
 2. The handle assembly (100)according to claim 1, wherein the knob (9) comprises a gear pattern orteeth (911); wherein the force limiter comprises a first ring elementcomprising a gear pattern or teeth (1551) matching or corresponding tothe gear pattern or teeth (911) of the knob (9); and wherein the forcelimiter comprises at least one spring element arranged for pressing thefirst ring element against the knob (9) such that a rotation of the knob(9) is transmitted onto the first ring element by means of the gearpattern or teeth of the knob (9) and the gear pattern or teeth of thefirst ring element (15).
 3. The handle assembly (100) according to claim2, wherein the first ring element comprises teeth (1511) on an innersurface (151) thereof.
 4. The handle assembly (100) according to claim2, wherein the force limiter further comprises a second ring element;wherein the spring element is interposed between the first ring elementand the second ring element and has contact to both of them.
 5. Thehandle assembly (100) according to claim 1, wherein one of the first andthe second ring element comprises protrusions (1311); and wherein theother one of the first and the second ring elements comprises orreceptions (1531) arranged for receiving the protrusions (1311) so as toestablish at least one of a form fit and a force disclosure between thefirst and the second ring elements (13, 15).
 6. The handle assembly(100) according to claim 5, wherein the receptions (1531) and theprotrusions (1311) are each arranged at on lower surface of the firstring element (15) and on the upper surface of the second ring element(13).
 7. The handle assembly (100) according to claim 1, wherein theforce limiter further comprises an internal retaining ring (39) attachedwithin the lumen of the knob (9).
 8. An implant delivery apparatuscomprising at least one handle assembly (100) according to claim
 1. 9.The implant delivery apparatus according to claim 8, designed orembodied as a catheter, in particular a heart catheter, or comprisingsuch a catheter.
 10. The implant delivery apparatus according to claim8, comprising at least one implant connected with tension threads forthe purpose of folding and/or unfolding or provided or prepared forbeing connected with tension threads.
 11. The implant delivery apparatusaccording to claim 10, wherein the implant is a stent or a heart valvearrangement.
 12. The handle assembly (100) according to claim 3, whereinthe force limiter further comprises a second ring element; wherein thespring element is interposed between the first ring element and thesecond ring element and has contact to both of them.
 13. The implantdelivery apparatus according to claim 9, comprising at least one implantconnected with tension threads for the purpose of folding and/orunfolding or provided or prepared for being connected with tensionthreads.
 14. The handle assembly (100) according to claim 2, wherein oneof the first and the second ring element comprises protrusions (1311);and wherein the other one of the first and the second ring elementscomprises or receptions (1531) arranged for receiving the protrusions(1311) so as to establish at least one of a form fit and a forcedisclosure between the first and the second ring elements (13, 15). 15.The handle assembly (100) according to claim 2, wherein the forcelimiter further comprises an internal retaining ring (39) attachedwithin the lumen of the knob (9).